Cure
Overview
These companies are building procedure-driven devices with a clear path to FDA clearance and commercialization.
U.S. digital health startups pulled in $14.2 billion in 2025, a 35 percent jump from 2024 and the highest total since 2022. Most of that money chased the same bet on AI that cuts costs inside healthcare systems already stretched thin.
At the same time, regulated medical devices remain a steady growth market. The FDA's device center reported 124 novel device authorizations in 2025, compared to a record 132 during the pandemic in 2020.
"In my experience, teams are better positioned to succeed when they design reimbursement strategy and clinical evidence into the product from day one, targeting large, reimbursed populations," says Charles Dresser, JD, Partner and Patent Attorney at Caldwell Law. "Ultimately, innovation that reduces burden for clinicians while improving patient outcomes will be most successful."
The demand isn't going away. Healthcare systems are still under pressure to improve efficiency and control costs, and the shift toward value-based care keeps raising the bar for what technology needs to prove before it gets adopted.
"The growing use of artificial intelligence and data analytics is helping improve clinical workflows, support more accurate diagnoses, and enable more tailored treatment approaches as healthcare organizations generate increasing amounts of complex data," says Tasneem Dohadwala, Founding Partner at Excelestar Ventures, a MedTech investment firm. But she adds that the real work is in the infrastructure: data governance, internal AI frameworks, and standardized data management practices across markets.
We've identified companies showcasing procedure-driven innovation with a clear path to FDA clearance or commercialization.
Eko Health
Sector: Smart digital stethoscopes and AI diagnostics
HQ: Emeryville, CA
Year Founded: 2013
Origin Story: While attending UC Berkeley to obtain a bioengineering degree, classmates Connor Landgraf, Jason Bellet, and Tyler Crouch decided to develop an improved stethoscope for their senior thesis.
Key Leaders: Connor Landgraf, Co-Founder and CEO; Jason Bellet, Co-Founder and Chief Business Officer; Steven Steinhubl, MD, Chief Medical Officer
Number of Employees: ~180
Stage: Late-stage venture capital
Financial Snapshot: In June 2024, raised $41 million in Series D funding and hasraised a total of about $195 million.
Notable Investors: Artis Ventures, EDBI, DigiTx Partners, Double Point Ventures, Highland Capital Partners, LG Technology Ventures, Mayo Clinic, Morningside Technology Ventures Limited, NTTVC, Questa Capital
Key Products: Eko CORE, a small attachment that turns an analog stethoscope into a digital one; 3M Littmann CORE Digital Stethoscope, which is a cardiology-grade stethoscope enhanced by Eko’s CORE digital technology; SENSORA platform supports clinicians by flagging structural murmurs and low ejection fraction during the physical exam
Recent Highlights: In July 2025, the American Medical Association issued a new Category III CPT code for Eko Health’s AI-enabled cardiac analysis platform, SENSORA.
Sempulse
Sector: Wearable vital‑sign monitors for clinical and emergency use
HQ: San Marcos, TX
Year Founded: 2016
Origin Story: The company developed its Halo monitor platform for military training and field triage, law enforcement and border operations, and industrial and clean-room facilities.
Key Leaders: Kurt Stump, CEO; Matt Barrera, Director of Medical Operations
Number of Employees: ~8
Stage: Series A
Financial Snapshot: Received project‑related funding and support from military‑linked programs for technology development, including the Military Infectious Disease Research Program and MTEC
Notable Investors: MassChallenge accelerator program provided non‑equity assistance in 2018; investors include Ecliptic Capital, United States Air Force, United States Department of War, Texas Health Catalyst
Key Products: Halo platform provides continuous, clinical-grade physiological monitoring in a wide range of environments and extreme conditions. It supports medical settings such as emergency departments, intensive care units, telemedicine, and remote patient monitoring.
Recent Highlights: In May 2025, Sempulse received FDA clearance for its Halo Vital Signs Monitoring System. The development of this system was supported by the Military Infectious Disease Research Program, Military Operational Medicine Research Program, and MTEC.
AliveCor
Sector: ECG hardware and rhythm detection systems for mobile devices paired with proprietary AI for arrhythmia detection
HQ: Mountain View, CA
Year Founded: 2010
Key Leaders: Priya Abani, CEO; David E. Albert, MD, Founder and Chief Medical Officer; Siva Somayajula, Chief Technology Officer; Ben Green, MD, Chief Clinical Officer; Alfred Woo, Chief Product Officer
Number of Employees: ~200
Stage: Late-stage venture-backed company
Financial Snapshot:The company has raised roughly $318 million.
Notable Investors: Khosla Ventures, GE Healthcare Technologies, Pegasus Tech Ventures, Sweetwater Private Equity, Huami Corp, Mayo Clinic, Omron Healthcare
Key Products: KardiaMobile 6L device is a personal ECG solution.
Recent Highlights:In January 2026, AliveCor announced FDA clearance of new cardiac determinations for Kardia 12L ECG System, bringing the total to 39. In February 2026, AliveCor announced a strategic partnership to expand cardiac safety monitoring capabilities in clinical research with Ametris.
Promaxo
Sector: Medical imaging, robotics and AI
HQ: Oakland, CA
Year Founded: 2016
Origin Story: While Amit Vohra, PhD, MBA, was working on his MBA at Duke, he came across the concept for NIH-funded portable MRI technology at a NC Biotechnology Center event. From there, he went on to found the company and built the MRI from a concept to a clinically validated product.
Key Leaders: Amit Vohra, PhD, President and CEO; Dinesh Kumar, PhD, Chief Operations Officer
Number of Employees: ~58
Stage: Later stage VC
Financial Snapshot:The company has raised about $99.1 million across 12 funding rounds.
Notable Investors: Zynext Ventures, Fred Moll, MD, Zepp Health, Angels Physicians Fund, Band of Angels, iO Life Ventures, K2X
Key Products: Promaxo MRI System features single-sided design that provides accessibility for both physicians and patients in various clinical settings; Promaxo Robot leverages real-time imaging and AI to automate and enhance the precision of prostate biopsies and cancer treatments.
Recent Highlights: In January 2024, the company announced sales of 69 of its single-sided MRI with AI based imaging systems for the 2023 year.
nView medical
Sector: AI‑enhanced surgical imaging and navigation
HQ: Salt Lake City, UT
Year Founded: 2012
Key Leaders: Cristian Atria, Founder and CEO; Lisa Last, Chief Operating Officer
Number of Employees:~12
Stage: Crowdfunding
Financial Snapshot: The company has a valuation of about $30 million.
Notable Investors: HeartX Accelerator, Knox Capital, Orthofix Medical, Fusion Fund, HealthTech Arkansas Programs
Key Products: nView s1 uses insta-3D technology to provide 3D images without rotating around the patient and quantum-dose technology that uses a fraction of the radiation dose.
Recent Highlights: In April 2025, the company announced it successfully surpassed 500 surgeries and that it launched a community crowdfunding campaign on StartEngine.
Omeza
Sector: Advanced wound care devices and skin substitute matrix
HQ: Sarasota, Florida
Year Founded: 2014
Origin Story: Omeza was founded by Thomas Gardner, a global pharmaceutical and skin care executive, and Griscom (Chip) Bettle, a renowned chemical engineer and inventor. They partnered with Desmond Bell, DPM, who is a leader in limb salvage and lower extremity wound care, to create a product that increases the healing rate of venous leg ulcers and diabetic foot ulcers.
Key Leaders: Thomas Gardner, Founder and CEO; Griscom Bettle, Chief Innovations Officer; Suzanne Bakewell, PhD, Chief Scientific Officer; Desmond Bell, DPM, Chief Medical Officer
Number of Employees: ~16
Stage: Later stage VC
Financial Snapshot: Raised approximately $13 million in three rounds.
Notable Investors: Florida Opportunity Fund, EQT Life Sciences, Gimv
Key Products: OmezaCollagen Matrix is a drug-device combination product for wound healing; other products include Omeza Lidocaine Lavage and Omeza Skin Protectant
Recent Highlights: In May 2025, Advanced Solution, a national leader in regenerative medicine distribution, announced an exclusive partnership with Omeza Inc. to launch and commercialize OCM, a next-generation multi-modal matrix product designed to revolutionize chronic wound healing and soft tissue repair.
Venostent
Sector: Bioabsorbable perivascular wrap supports blood vessel healing after surgeries like arteriovenous fistula creation for dialysis access
HQ: Houston, TX
Year Founded: 2017
Origin Story: The company was inspired while co-founder Tim Boire was getting his PhD in biomedical engineering at Vanderbilt University. He developed 3D-printed bioabsorbable polymers aimed at strengthening blood vessels after dialysis vascular access surgery, specifically to reduce the high failure rates of arteriovenous fistulas.
Key Leaders: Tim Boire, PhD, CEO and Co-Founder; Geoff Lucks, Chief Operating Officer and Co-Founder; Mark Barakat, MD, VP of Clinical Affairs
Number of Employees: ~35
Stage: Private
Financial Snapshot:The company has raised about $28.13 million over 15 rounds.
Notable Investors: Alumni Ventures, Baylor Angel Network, Good Growth Capital, National Institutes of Health, Norwest Venture Partners
Key Products: SelfWrap, a bioabsorbable, smart polymer wrap designed to improve the maturation and durability of arteriovenous fistulas for hemodialysis patients
Recent Highlights: In January 2024, the company enrolled its first patients in a 200-Subject US Clinical Trial.
ZETA
Sector: AI-assisted surgical navigation and robotics for neurosurgery and non-invasive brain procedures
HQ: Boston, MA
Year Founded: 2018
Origin Story: Founded by Harvard graduates Jose Amich and Raahil Sha with Harvard Medical School neurosurgeon William Gormley, who all had the goal to use technology to improve neurosurgery.
Key Leaders: William Gormley, MD, Co-Founder; Jose Maria Amich, Co-Founder and CEO;
Raahil Sha, Co-Founder and CTO
Number of Employees: ~12
Stage: Later stage VC
Financial Snapshot: The company has raised about $8.9 million.
Notable Investors: Innospark Ventures, Y Combinator, First Star Ventures, TSV Capital, Valera Capital
Key Products: Zeta TMS Navigation System, is a guidance system that uses computer vision, mixed reality, and AI to track instruments in real-time with sub-millimeter accuracy
Recent Highlights:In October 2025, Zeta announced FDA clearance for its Surgical AI-Powered TMS Navigation System. And, in February 2026, the company announced the publication of a patent for its REALTRACK vision.
